title: A study in contrasts: eligibility criteria in a twenty-year sample of NSABP and POG clinical trials. National Surgical Adjuvant Breast and Bowel Program. Pediatric Oncology Group.
abstract: We studied changes in eligibility criteria--the largest impediment to patient accrual--in two samples of clinical trials. Trials from the NSABP (National Surgical Adjuvant Breast and Bowel Program) and POG (Pediatric Oncology Group) were analyzed. After eliminating duplications, the criteria in each protocol were enumerated and classified according to a novel schema. NSABP trials contained significantly more criteria than POG trials, and added precision criteria (making study populations homogeneous) at a faster rate than POG studies. The difference between NSABP studies (explanatory trials) and POG studies (pragmatic trials) suggest that large numbers of eligibility criteria are not necessary for quality studies. We recommend that: (1) the inclusion/exclusion criteria distinction be abandoned; (2) eligibility criteria be explicitly justified; (3) the need for each criterion be assessed when new trials are planned; (4) criteria in phase III trials restricting patient accrual be minimized; and (5) further research be done to assess the impact of criteria on generalizability.
authors.affiliation: Faculty of Medicine, McGill University, Montreal, Quebec, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Fuks
authors.forename: C
authors.initials: C
authors.lastname: Weijer
authors.forename: B
authors.initials: B
authors.lastname: Freedman
authors.forename: S
authors.initials: S
authors.lastname: Shapiro
authors.forename: M
authors.initials: M
authors.lastname: Skrutkowska
authors.forename: A
authors.initials: A
authors.lastname: Riaz
mesh_terms: D001943:Breast Neoplasms / Q000628:therapy*; D002170:Canada; D002648:Child; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards / Q000706:statistics & numerical data; D003131:Combined Modality Therapy; D016001:Confidence Intervals; D004992:Ethics, Medical; D005260:Female; D006801:Humans; D016014:Linear Models; D018579:Patient Selection; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000628:therapy*; D018709:Statistics, Nonparametric; D013997:Time Factors